Zhi Tong Cai Jing·2025-10-21 07:11Core Viewpoint - Kangfang Biopharma (09926) announced that its drug Iwosimab (PD-1/VEGF dual antibody) combined with chemotherapy achieved the primary endpoint of progression-free survival (PFS) in a Phase III clinical study for advanced squamous non-small cell lung cancer (sq-NSCLC), outperforming the comparator drug Tislelizumab combined with chemotherapy [1] Group 1: Clinical Research and Results - The HARMONi-6 study demonstrated that Iwosimab combined with chemotherapy significantly extended PFS compared to Tislelizumab combined with chemotherapy, with a median PFS of 11.14 months for Iwosimab versus 6.90 months for Tislelizumab (HR=0.60, P<0.0001), resulting in an absolute difference of 4.24 months [1] - Based on the positive results from the HARMONi-6 study, the supplemental new drug application (sNDA) for Iwosimab combined with chemotherapy for sq-NSCLC was accepted by the National Medical Products Administration (NMPA) in July 2025 and is currently under review [1] Group 2: Drug Approvals and Pipeline - Iwosimab has been included in the National Medical Insurance Drug List, with 13 Phase III clinical studies ongoing, covering various cancers including lung cancer, cholangiocarcinoma, and head and neck squamous cell carcinoma [2] - Iwosimab has received approval for two indications in China, with the first being for locally advanced or metastatic non-squamous NSCLC after progression on EGFR-TKI therapy, which has been successfully included in insurance; the second indication for PD-L1 positive locally advanced or metastatic NSCLC is expected to receive NMPA approval in April 2025 [2] - The drug Kadunili has also received approval for a new indication in first-line treatment of cervical cancer, with approximately 10 Phase III or registration clinical trials actively progressing [2]